FDA 510(k)

Disposable Monopolar Laparoscopic Shafts and Reusable Handles

K-Number: K210569 · 2021-08-16

Decision Date2021-08-16

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Disposable Monopolar Laparoscopic Shafts and Reusable Handles is a medical device manufactured by Dannik, LLC. It received FDA 510(k) clearance on 2021-08-16 under approval number K210569. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Monopolar Laparoscopic Shafts and Reusable Handles?

Disposable Monopolar Laparoscopic Shafts and Reusable Handles is a medical device that received FDA 510(k) clearance on 2021-08-16. It is manufactured by Dannik, LLC. The 510(k) number is K210569.

When was Disposable Monopolar Laparoscopic Shafts and Reusable Handles approved by the FDA?

Disposable Monopolar Laparoscopic Shafts and Reusable Handles received FDA 510(k) clearance on 2021-08-16, under approval number K210569.

What company makes Disposable Monopolar Laparoscopic Shafts and Reusable Handles?

Disposable Monopolar Laparoscopic Shafts and Reusable Handles is manufactured by Dannik, LLC.

What is the FDA product code for Disposable Monopolar Laparoscopic Shafts and Reusable Handles?

The FDA product code for Disposable Monopolar Laparoscopic Shafts and Reusable Handles is GEI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.